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Human Drug Products: A Basic Primer

Previously we talked about medical device registration, Today, we’re sharing some insight on the human drug products process.

The first thing you’ll need to do is obtain a DUNS number. If the drug product is finished and under OTC monograph, you can proceed to the labeling. If it is not under OTC monograph, then you may need to apply for NDA/ANDA. If the drug product is unfinished, you can proceed to the labeling phase.

Next, you’ll need to determine whether you manufacture, repack, relabel, or analyze. If you do, the establishment can be registered, if not then you’ll need to obtain a labeler code for PLD. Is the establishment based in the U.S.? If so, make sure to designate a regulatory contact. Otherwise, you’ll need to designate a U.S. agent and a regulatory contact.

Speaking of the PLD labeler code, determine whether the product is a generic drug. If analysis is the sole function, you can proceed with listing the product depending on whether or not the product is generic. If analysis is not the sole function, a labeler code will be required.

A&L Registration is committed to assisting domestic and foreign clients in navigating and simplifying the often convoluted process of registering with the FDA. We have worked with an extensive array of clients across a broad spectrum of industries such as cosmetics, food and beverage, medical devices, and more through providing experienced, researched, and professional advice on FDA compliance and its multitude of legal regulations. For more information on FDA registration, please visit our website or call 786-504-6363.

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